Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection - Full Text View

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00376597

Purpose

RATIONALE: A personalized exercise program, counseling, and education materials may be more effective than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection.

PURPOSE: This randomized clinical trial is studying how well education with or without exercise and counseling works in preventing lymphedema in women with stage I, stage II, or stage III breast cancer who are undergoing axillary lymph node dissection.

Condition	Intervention
Breast Cancer Cancer-Related Problem/Condition	Procedure: complementary or alternative medicine procedure Procedure: conventional surgery Procedure: counseling Procedure: educational intervention Procedure: exercise intervention Procedure: management of therapy complications Procedure: quality-of-life assessment

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness Lymphedema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Active Control
Official Title:	A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Lymphedema incidence (percentage of women who remain free from the presence of lymphedema for 18 months) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Severity of lymphedema as assessed by changes in arm circumference [ Designated as safety issue: No ]
Agreement between patients' self-report of swelling and the extent of circumferential measurement difference between the treated side and the contralateral arm [ Designated as safety issue: No ]
Health-related quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) +4 score [ Designated as safety issue: No ]
Adherence to lymphedema prevention exercises, lymphedema knowledge, range of motion, and arm strength [ Designated as safety issue: No ]

Estimated Enrollment:	560
Study Start Date:	June 2006
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the efficacy of a comprehensive program of tailored exercise, lymphedema prevention patient education, and counseling vs lymphedema prevention patient education only in reducing the incidence of lymphedema in women with stage I-III breast cancer who are undergoing axillary lymph node dissection.

Secondary

Compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable, in patients undergoing these interventions.
Assess the agreement between patients' self-report of swelling (mild, moderate, or severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference (< 0.5 inches vs ≥ 0.5 and < 2 inches vs ≥ 2 inches).
Compare the health-related quality of life of these patients.
Characterize adherence to lymphedema prevention exercises, lymphedema knowledge, range of motion, and arm strength.

OUTLINE: This is a randomized, controlled, multicenter study where the unit of randomization is the participating center. Participating centers are stratified according to the annual number of patients with stage I-III breast cancer who undergo axillary node dissection at the center (small vs moderate vs large number of patients) and are randomized to 1 of 2 arms. Patients are thus randomized to 1 of 2 intervention arms based on the identified participating center.

All patients complete questionnaires prior to surgery regarding lymphedema knowledge, health-related quality of life, fear of cancer recurrence, self-efficacy, body-image, self-report of range of motion, arm circumference, and demographics. Patients then undergo surgery, which must include axillary node dissection.

Arm I: Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.
Arm II: Patients receive lymphedema education and complete physical assessments and questionnaires as in arm I. Patients also complete a personalized exercise regimen and receive a 15-minute video that reinforces information and exercises.

PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer
- Newly diagnosed disease
- Stage I-III disease
No diagnosed lymphedema
Must have arm measurements for axilla, elbow, and wrist that fall within the ranges for one of six sleeve sizes (i.e., all three measurments must be found in one column) available
Scheduled to undergo axillary node dissection with ≥ 10 nodes removed
- No sentinel axillary node dissection only
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Female
Menopausal status not specified
No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease that, in the opinion of the investigator, significantly reduces mortality over the next 2 years
May not be currently homebound or dependent upon a walker or wheelchair for mobility
Able to participate in a mild exercise program
No prior history of carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer
- Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis
- Patients with basal cell and squamous cell carcinoma of the skin are eligible

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior double mastectomy, axillary node dissection, and/or radiotherapy involving both arms
May be enrolled on other treatment trials except surgery trials where one treatment arm involves full axillary node dissection
Any type of radiotherapy to the breast or axilla allowed
Neoadjuvant treatment for this cancer allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376597

Show 37 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Electra D. Paskett, PhD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000494652, CALGB-70305
Study First Received:	September 13, 2006
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00376597
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

lymphedema
perioperative/postoperative complications
stage I breast cancer
stage II breast cancer

stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Study placed in the following topic categories:

Lymphedema
Lymphatic Diseases
Skin Diseases

Postoperative Complications
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009